Senior Manager, Sterile DP Manufacturing OperationsLocation Cork, Ireland Apply
BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients’ lives.
Having just obtained approval to establish internal Sterile Drug Product Filling operations at the Shanbally site, we at BioMarin are now looking to commence hiring for key technical and leadership positions. Initially these roles will support the capital project execution, product transfers and operational readiness activities before moving into routine operational support. This facility will contain a state of the art flexible line using isolator technology for filling of vials and syringes and the facility will support both clinical and commercial filling for the majority of the BioMarin biologics product portfolio.
Reporting to the Director, Sterile DP Manufacturing Operations, the primary role of the Sterile DP Manufacturing Operations Manager is to establish and lead the sterile filling operations team through successful operational readiness and start up activities including; hiring technicians, writing SOPs and batch records, attendance at FATs, running engineering and media fills, GMP certification and execution of PQ fills.
Once operational readiness efforts are complete it is expected the Sterile DP Manufacturing Operations Manager will deliver day to day manufacturing requirements by leading a high-performing, team based organization, where colleagues are flexible, multi-skilled and empowered to make decisions that result in safe, agile and compliant manufacture of sterile Drug Product material. A high level of initiative, energy and motivation are key role requirements, as well as organizational and people management skills.
The Sterile DP Manufacturing Operations Manager will report to the Director, Sterile DP Manufacturing Operations.
- Hire a group of experienced and enthusiastic biotechnicians as part of start-up of Sterile filling operations on site at Shanbally.
- Manage biotechnicians through the construction project, C&Q, technical transfer activities, process validation and site regulatory inspections.
- Lead and support the Sterile filling team in the production of drug product under cGMP conditions.
- Develop and lead the sterile filling team in areas of technical expertise, embed the use of Business Process Engineering tools, and coach and mentor high performance team behaviours.
- Participate in budget planning and headcount planning. Communicate capital equipment needs, facility needs, team needs; and contract service requirements
- Influence, support and partner closely with sterile DP technical services, process engineers, Biotechnicians and other colleagues to ensure master batch records, SOPs and other documents are generated and maintained as current and compliant under cGMP conditions – ensure manufacturing systems and practices are consistent throughout the organization.
- Lead, coach and support daily operation of sterile filling and visual inspection equipment and partner with plant engineering colleagues to ensure equipment is reliably maintained and within appropriate calibration.
- Partner with validation subject matter experts, prepare/approve validation protocols, validation plans, protocol executions, and summary reports in support of ongoing revalidation and validation efforts required for commercial manufacturing.
- Embed the use of six sigma and lean manufacturing practices leading to operational excellence.
- Represent Sterile DP Manufacturing team as necessary at critical meetings including tech transfer, quality and project meetings.
- Develop and demonstrate a proactive approach to safety, industrial hygiene, environmental and regulatory compliance
- Participate and support plant optimization that helps create a strong value proposition for future investment.
- Lead and demonstrate strong stakeholder management in terms of interfacing with other BioMarin departments (Regulatory Affairs, Quality control, Quality Assurance, Facilities, etc.) and contractors as necessary.
Work Environment / Physical Demands
This would arise from time spent primarily at equipment manufacturers for design, engineering runs and FATs. Other travel would include the BioMarin facilities in Marin County, US.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Degree in Science / Engineering, Operations Management, or Industrial Engineering required
- Other continuing education initiatives highly desirable (e.g. Six Sigma, Lean Manufacturing, industry specific coursework)
- At least 8 years GMP/GCP compliant Biopharma operations experience required
- 5 years of directly related experience in aseptic drug product manufacturing environment.
- Past experience and demonstrated ability to successfully influence team performance is strongly preferred.
- Strong demonstrated ability in the area of communication and strong ability to interact within cross-functional teams.
- Demonstrated ability coach colleagues in processing, operational excellence, team interactions and delivering results.
- Experience with regulatory inspections and direct interaction with regulatory inspectors.
- Highly developed organizational and leadership skills.
- Process development and/or technology transfer experience preferred.
- Track record of embedding a strong Quality culture. Trackwise experience preferred.
- Demonstrated ability to partner with other functional groups to achieve business objectives required
- Strong knowledge of cGMPs (US & EU), OSHA, ISO, and other regulatory agency standards and requirements applicable to a pharmaceutical production facility.
- Creative problem solving skills
- Comfortable and effective working indirectly through others
- Builds partnerships and works collaboratively with others to meet shared objectives.
- Develops and delivers communications which convey a clear understanding of the unique needs of different audiences;
- Skilled influencer; able to distill complex concepts into concise, salient points.
- Holds self and others accountable to meet commitments by following through, acting with a clear sense of ownership, and taking personal responsibility for decisions, actions and failures.
- Develops people to meet both their career goals and the organization’s goals through coaching, feedback, exposure and stretch assignments;
- Effectively develop successful leaders and high performing teams.
Drives Vision and Purpose
- Paints a compelling picture of the vision and strategy which motivates others to action.
- Understands interdependencies, trends, issues and opportunities; able to synthesize complex information and translate into mid to long-range goals and plans.
- Credible, trustworthy and empathetic leader; calm under pressure; can do attitude; relates openly and comfortably with diverse groups of people.
- Handles multiple projects and priorities simultaneously; operates effectively, even when things are not certain or the way forward is unclear.
- Able to work in a variety of roles and settings, with a diverse group of people and/or functions.
- Able to prioritize and focus on the few critical objectives;
- Design simple, flexible organizational structures and systems that can align and adapt with evolving strategy.
- Effectively adjusts to new, changing and unpredictable situations; able to learn new things quickly and easily; solicits and responds to feedback and coaching
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.